Spinal fixation devices and methods of use

ABSTRACT

Disclosed is an orthopedic implant and methods of implantation for fixing adjacent bones. In an embodiment, the implant includes a locking mechanism that is adapted to be advanced by a locking instrument, wherein advancement of the locking mechanism in a first direction produces rotation of a first rigid abutment surface from a first orientation to a second orientation, and continued advancement of the locking mechanism produces advancement of the first rigid abutment surface towards a second rigid abutment surface and placement of a compressive load onto and sufficient to immobilize the implant relative to the first bony surface and the second bony surface.

REFERENCE TO PRIORITY DOCUMENT

This application is a continuation of and claims priority to co-owned,co-pending U.S. patent application Ser. No. 12/940,960 filed on Nov. 5,2010 and issuing as U.S. Pat. No. 8,795,335 on Aug. 5, 2014, which isincorporated herein by reference in its entirety, and which claimspriority of U.S. Provisional Patent Application Ser. No. 61/280,666,entitled “Spinal Fixation Devices and Methods of Use” by Samy Abdou andWilliam Taylor, filed Nov. 6, 2009. Priority of the filing date of Nov.6, 2009 is hereby claimed, and the disclosure of the provisional patentapplication is hereby incorporated by reference in its entirety.

BACKGROUND

This disclosure relates generally to bone fixation systems, componentsthereof, and methods of implant placement used to adjust, align andmaintain the spatial relationship(s) of adjacent bones or bony fragmentsafter surgical reconstruction of skeletal segments. In particular, thisdisclosure relates to devices that fixate the spinous processes at onevertebral level with the spinous process of another vertebra.

Whether from degenerative disease, traumatic disruption, infection orneoplastic invasion, alteration in the anatomical relationships betweenthe spinal vertebras can cause significant pain, deformity anddisability. Spinal disease is a major health problem in theindustrialized world and the surgical treatment of spinal pathology isan evolving discipline. The traditional surgical treatment of abnormalvertebral motion is the complete immobilization and bony fusion of theinvolved spinal segment and an extensive array of surgical techniquesand implantable devices have been formulated to accomplish the treatmentobjective.

Regardless of the specific objectives of surgery, many surgeons employimplantable devices that maintain the desired spatial relationship(s)between adjacent vertebral bodies. The effectiveness of theses devicesis critically dependant on adequate fixation into the underlying bone.While screw fixation into the pedicle portion of the vertebral body hasemerged as a common method of device fixation, it remains a substantialoperation with multiple shortcomings.

SUMMARY

There remains a need for improved devices for adequately fixing anddecompressing adjacent bones in the spinal canal in a minimally invasivemanner that can be implanted without excessive manipulation andrepositioning of the patient during the procedure.

In a first aspect, disclosed is an orthopedic implant for fixingadjacent bones. The implant includes an elongated body extending along acentral axis from a first segment to a second segment, and a first rigidabutment surface positioned at the first segment of the elongated body.The first rigid abutment surface is adapted to abut a first bony surfaceof a bone segment, and the first rigid abutment surface has a long axis.The implant also includes a second rigid abutment surface positioned atthe second segment of the elongated body. The second rigid abutmentsurface is adapted to abut a second bony surface of the bone segment.The implant also includes a locking mechanism that is at least partiallypositioned at the second segment of the elongated body and adapted to beadvanced by a locking instrument. Advancement of the locking mechanismin a first direction produces rotation of the first rigid abutmentsurface from a first orientation to a second orientation. The long axisof the first rigid abutment surface is substantially parallel to thecentral axis of the elongated body when in the first orientation and thelong axis of the first rigid abutment surface is substantiallyperpendicular to the central axis of the elongated body when in thesecond orientation. Continued advancement of the locking mechanismproduces advancement of the first rigid abutment surface towards thesecond rigid abutment surface and placement of a compressive load ontothe first bony surface and the second bony surface. The compressive loadis sufficient to immobilize the implant relative to the first bonysurface and the second bony surface.

At least the first rigid abutment surface can have at least onesharpened protrusion that is adapted to penetrate and anchor onto thefirst bony surface. The compressive load can forcibly advance the atleast one sharpened protrusion into the first bony surface. The secondrigid abutment surface can have at least one sharpened protrusion thatis adapted to penetrate and anchor onto the second bony surface. Thecompressive load can forcibly advance the at least one sharpenedprotrusion into the second bony surface. The locking mechanism can befurther adapted to retain the compressive load placed onto the firstbony surface and the second bony surface after disengagement of thelocking instrument from the locking mechanism. Rotation of the firstrigid abutment surface from the first orientation to the secondorientation can be reversed by advancement of the locking mechanism in asecond direction that is opposite to the first direction.

In another aspect, disclosed is a method for the percutaneousdecompression of the spinal canal. The method includes identifying onX-ray a spinal level to be decompressed; making an incision that islateral to the vertebral midline; and advancing an orthopedic implantinto an interspinous space of the spinal level to be decompressed. Theimplant includes an elongated body extending along a central axis from afirst segment to a second segment, and a first rigid abutment surfacepositioned at the first segment of the elongated body. The first rigidabutment surface is adapted to abut a first bony surface of a bonesegment, and the first rigid abutment surface has a long axis. Theimplant also includes a second rigid abutment surface positioned at thesecond segment of the elongated body. The second rigid abutment surfaceis adapted to abut a second bony surface of the bone segment. Theimplant also includes a locking mechanism that is at least partiallypositioned at the second segment of the elongated body and adapted to beadvanced by a locking instrument. Advancement of the locking mechanismin a first direction produces rotation of the first rigid abutmentsurface from a first orientation to a second orientation. The long axisof the first rigid abutment surface is substantially parallel to thecentral axis of the elongated body when in the first orientation and thelong axis of the first rigid abutment surface is substantiallyperpendicular to the central axis of the elongated body when in thesecond orientation. Continued advancement of the locking mechanismproduces advancement of the first rigid abutment surface towards thesecond rigid abutment surface and placement of a compressive load ontothe first bony surface and the second bony surface. The compressive loadis sufficient to immobilize the implant relative to the first bonysurface and the second bony surface.

In another aspect, disclosed is a method for the anterior and posteriordecompression of the spinal canal between a first superior vertebralbone and a second inferior vertebral bone. The method includesidentifying on X-ray a spinal level to be decompressed; placing a firstorthopedic implant into the anterior column of the spinal level to bedecompressed. The first implant is positioned within the disc spacebetween the first superior vertebral bone and the second inferiorvertebral bone. The method also includes advancing a second orthopedicimplant into an interspinous space between the spinous processes of thefirst superior vertebral bone and the second inferior vertebral bone.The second implant is advanced into the interspinous space in apercutaneous manner. The second implant is adapted to rigidly immobilizethe spinous processes of the first superior vertebral bone and thesecond inferior vertebral bone relative to one another. The secondimplant includes an elongated body extending along a central axis from afirst segment to a second segment, and a first rigid abutment surfacepositioned at the first segment of the elongated body. The first rigidabutment surface is adapted to abut a first bony surface of a bonesegment, and the first rigid abutment surface has a long axis. Thesecond implant also includes a second rigid abutment surface positionedat the second segment of the elongated body. The second rigid abutmentsurface is adapted to abut a second bony surface of a bone segment. Thesecond implant also includes a locking mechanism that is adapted to beengaged by a locking instrument. Advancement of the locking mechanism ina first direction produces advancement of the first rigid abutmentsurface towards the second rigid abutment surface and placement of acompressive load onto the first bony surface and the second bonysurface. The applied compressive load is sufficient to immobilize thesecond implant relative to the spinous processes of the first and secondvertebral bones.

In another aspect, disclosed is a device for the treatment of abnormalspinal stability and stenosis of the spinal canal. The device includes aplate member having a first abutment surface and an opening extendingthrough a portion of the plate member; a deployment element having across-sectional shape complementary to the opening of the plate memberand an inner threaded surface; a locking mechanism that engages theinner threaded surface of the deployment member to produce downwardtranslation of the deployment member through the opening of the platemember; and a rotation arm moveably coupled to the deployment elementand having a second abutment surface extending outward from a centralhinge element.

In yet another aspect, a method for fusion of a spinal segmentcomprising a superior vertebral bone, an immediately adjacent inferiorvertebral bone and an intervening intervertebral disc space of a subjectis disclosed. In one embodiment, the method comprises: (i) identifyingthe spinal segment on an imaging modality; (ii) advancing a firstimplant into the intervertebral disc using a first corridor within thesubject that extends from a first lateral skin incision, through a psoasmuscle and onto a lateral side surface of the intervertebral disc space;(iii) positioning the first implant within the intervertebral disc spacethrough the first corridor; (iv) advancing a second implant through asecond corridor and onto a lateral aspect of an interspinous space, theinterspinous space being positioned between a spinous process of thesuperior vertebral bone and a spinous process of the inferior vertebralbone, the second implant comprising: an elongated body configured toextend along a longitudinal axis from a proximal segment to a distalsegment; a first bone abutment member configured to extend along alongitudinal axis from a proximal to a distal end and movably coupled tothe distal segment of the elongated body; and a second bone abutmentmember configured to extend along a longitudinal axis from a proximal toa distal end and coupled to the proximal segment of the elongated body;(v) positioning the elongated body of the second implant at leastpartially within the interspinous space, the first bone abutment memberbeing positioned on a side of the interspinous space contralateral tothe first lateral skin incision, and the second bone abutment memberbeing positioned on a side of the interspinous space ipsilateral to thefirst lateral skin incision; (vi) actuating a locking mechanism of thesecond implant, the act of actuating advancing the first and the secondbone abutment members towards one another; and (vii) immobilizing thespinous process of the superior vertebral bone relative to the spinousprocess of the inferior vertebral bone.

In another aspect, a method for stabilizing a spinal segment comprisinga superior vertebral bone, an immediately adjacent inferior vertebralbone and an intervening intervertebral disc space is disclosed. In oneembodiment, the method comprises: (i) identifying the spinal segmentusing an imaging modality; (ii) creating a first corridor configured toextend through a psoas muscle and onto a lateral side surface of theintervertebral disc space; (iii) advancing a first implant at leastpartially into the intervertebral disc space using the first corridor;(iv) advancing a second implant through a second corridor configured toextend onto a lateral aspect of an interspinous space positioned betweena spinous process of the superior vertebral bone and a spinous processof the inferior vertebral bone, the second corridor being ipsilateral tothe first corridor, and the second implant comprising: an elongated bodyconfigured to extend along a longitudinal axis from a proximal segmentto a distal segment; a first bone abutment member configured to extendalong a longitudinal axis from a proximal to a distal end and movablycoupled to the distal segment of the elongated body; and a second boneabutment member configured to extend along a longitudinal axis from aproximal to a distal end and coupled to the proximal segment of theelongated body; (v) advancing the second implant at least partially intothe interspinous space, the first and the second bone abutment membersof the second implant being positioned on opposing sides of at least oneof the spinous process of the superior vertebral bone and/or the spinousprocess of the inferior vertebral bone; (vi) performing a firstactuation of a locking mechanism of the second implant, the firstactuation thereof causing rotation of the longitudinal axis of the firstbone abutment member to a greater angle with respect to the longitudinalaxis of the elongated body; (vii) performing a second actuation of thelocking mechanism of the second implant, the second actuation thereofcausing translation of the bone abutment members toward one anotherwithout further rotation of the first bone abutment member relative tothe elongated body; and (viii) immobilizing the spinous process of thesuperior vertebral bone relative to the spinous process of the inferiorvertebral bone.

In a further aspect, a method for bony fusion of a first vertebral bone,an immediately adjacent second vertebral bone, and an interveningintervertebral disc space is disclosed. In one embodiment, the methodcomprises: (i) identifying the first and second vertebral bones on animaging modality; (ii) placing a skin incision posterior to a posterioraspect of a pedicle of an inferior one of the first and second vertebralbones; (iii) developing a first corridor to an ipsilateral facet jointfrom the incision, the facet joint comprising an articulation betweenthe first and second vertebral bones; (iv) removing at least a portionof the facet joint; (v) advancing at least a segment of a first implantinto the intervertebral disc space through a trans-foraminal corridor;(vi) developing a second corridor to the lateral aspect of aninter-spinous space, the inter-spinous space being positioned between aspinous process of the first vertebral bone and a spinous process of thesecond vertebral bone; (vii) positioning a second implant within theinterspinous space, the second implant comprising: an elongated bodyconfigured to extend along a longitudinal axis from a proximal segmentto a distal segment; a first bone abutment member configured to extendalong a longitudinal axis from a proximal to a distal end and movablycoupled to the distal segment of the elongated body; and a second boneabutment member configured to extend along a longitudinal axis from aproximal to a distal end and coupled to the proximal segment of theelongated body; (viii) positioning the elongated body of the secondimplant at least partially within the interspinous space, the first boneabutment member being positioned on a side of the interspinous spacecontralateral to the skin incision, and the second bone abutment memberbeing positioned on a side of the interspinous space ipsilateral to theskin incision; (ix) actuating a locking mechanism of the second implantto advance the first and the second bone abutment members towards oneanother; and (x) immobilizing the spinous process of the first vertebralbone relative to the spinous process of the second vertebral bone.

In yet another aspect, a method for anterior and posterior decompressionof a target spinal canal segment that is positioned between a superiorvertebral bone and an inferior vertebral bone is disclosed. In oneembodiment the method comprises: (i) identifying the target segment;(ii) placing a first implant within a disc space that is positionedbetween the superior vertebral bone and the inferior vertebral using afirst corridor configured to extend from a posterior skin incision andthrough at least a portion of a facet joint that forms an articulationbetween the superior and inferior vertebral bones; (iii) advancing asecond implant into an interspinous space between a spinous process ofeach of the superior and inferior vertebral bones, the second implantcomprising: an elongated body configured to extend along a longitudinalaxis from a proximal segment to a distal segment; a first bone abutmentmember configured to extend along a longitudinal axis from a proximal toa distal end and movably coupled to the distal segment of the elongatedbody; and a second bone abutment member configured to extend along alongitudinal axis from a proximal to a distal end and coupled to theproximal segment of the elongated body; (iv) positioning the first andsecond bone abutment members of the second implant on opposing sides ofat least one of the spinous processes of the superior and inferiorvertebral bones; (v) performing a first actuation of a locking mechanismof the second implant, the first actuation thereof causing rotation ofthe longitudinal axis of the first bone abutment member to a greaterangle with respect to the longitudinal axis of the elongated body; (vi)performing a subsequent actuation of the locking mechanism of the secondimplant, the subsequent actuation thereof causing translation of thebone abutment members toward one another without further rotation of thefirst bone abutment member relative to the elongated body; and (vii)immobilizing the spinous process of the superior vertebral bone relativeto the spinous process of the inferior vertebral bone.

The details of one or more embodiments are set forth in the accompanyingdrawings and description below. Other features, objects, and advantageswill be apparent from the following description, the accompanyingdrawings and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will now be described in detail with referenceto the following drawings. Generally speaking the figures are not toscale in absolute terms or comparatively but are intended to beillustrative. Also, relative placement of features and elements may bemodified for the purpose of illustrative clarity.

FIG. 1 is a perspective view of a first embodiment of a fixation device;

FIG. 2 is an exploded view of the device of FIG. 1;

FIGS. 3A-3C are various views of a diagrammatic representation of aspinal vertebral bone;

FIGS. 4A-4B are various views of a functional spinal unit including twoadjacent vertebral bones;

FIG. 5 is a cross-sectional view of a torso at the level of the lumbarspine;

FIG. 6 is a schematic representation of the posterior aspect of apatient;

FIGS. 7 A-7B are perspective views of a plate member according to oneembodiment;

FIGS. 8A-8B are perspective views of an advancing deployment memberaccording to one embodiment;

FIGS. 9A-9B are perspective views of a rotation arm according to oneembodiment;

FIGS. 10A-10C are various views of a locking nut;

FIGS. 11A-11 B are cross-sectional views of the fixation device of FIG.1 in a fully withdrawn state of the delivery configuration;

FIGS. 12A-12B are cross-sectional views of the fixation device of FIG. 1in a partially deployed state;

FIGS. 13A-13B are cross-sectional views of the fixation device of FIG. 1in a deployed state;

FIGS. 14A-14B are side views of the fixation device in the withdrawnstate;

FIGS. 15A-15B are side views of the fixation device in the deploymentstate;

FIG. 16A-16B is a side view of the fixation device in the fully deployedstate and the downward translation of fully rotated arms towards platemember;

FIGS. 17A-17B are perspective views of a fixation device in thewithdrawn state coupled to a deployment device;

FIGS. 18A-18B are perspective views of the deployment device of FIGS.17A-17B;

FIG. 19A shows a spine with an implant positioned within a disc spacebetween adjacent vertebrae;

FIG. 19B shows a tissue dilator positioned through a lateral corridor tothe spinous processes of the adjacent vertebrae;

FIGS. 20A-20B show placement of a larger tissue dilator over the tissuedilator of FIG. 19B;

FIGS. 21A-21 B show placement of a larger tissue dilator over the tissuedilators of FIGS. 20A-20B and FIG. 19B;

FIGS. 22A-22B show placement of a distraction device advanced into theinterspinous space created by the tissue dilators;

FIGS. 23A-23B show distraction using the distraction device of FIGS.22A-22B and dilation of the space between the spinous processes uponligament perforation;

FIGS. 24A-24B show guidance to the interspinous space the fixationdevice coupled to the deployment device and advancement into the spacebetween the spinous processes;

FIGS. 25A-25B show deployment of the fixation device from the withdrawnstate to the deployed state to capture the spinous processes andimmobilize them relative to one another;

FIGS. 26A-26B show the fixation device deployed and the deploymentinstrument and distraction device removed;

FIG. 27 A illustrates embodiments of bone graft material that can beincorporated with the fixation device;

FIG. 27B illustrates bone graft material implanted anterior to thefixation device;

FIGS. 27C and 27D illustrate an alternative method of implant placement;

FIG. 28A illustrates use of the fixation device together with a bonefusion implant positioned into the pedicle portion near the anteriorcolumn;

FIGS. 28B and 28C illustrate an alternative method of implant placement;

FIGS. 29A-29C illustrate another embodiment of a fixation device havinga plate with a “z” configuration;

FIGS. 30A-30C illustrate the fixation device of FIGS. 29A-29C implantedbetween two adjacent functional spinal units;

FIGS. 31A-31 E illustrate another embodiment of a fixation device;

FIGS. 32A-32B illustrate the implanted device of FIGS. 31A-31 E.

In order to promote an understanding of the principals of thedisclosure, reference is made to the drawings and the embodimentsillustrated therein. Nevertheless, it will be understood that thedrawings are illustrative and no limitation of the scope of the claimsis thereby intended. Any such alterations and further modifications inthe illustrated embodiments, and any such further applications of theprinciples of the disclosed devices as illustrated herein arecontemplated as would normally occur to one of ordinary skill in theart.

DETAILED DESCRIPTION

Described herein are devices, systems and methods for the treatment ofabnormal spinal stability and stenosis of the spinal canal by theimplantation of orthopedic devices between skeletal segments. Theimplanted devices can be used to adjust, decompress and maintain thespatial relationship(s) of adjacent bones. Depending on the implantdesign, the motion between the skeletal segments may be returned tonormal, increased, modified, limited or completely immobilized.

In a first embodiment, a device is disclosed that rigidly fixates thespinous processes of two adjacent vertebral bones relative to oneanother. In a preferred embodiment of device use, the implant ispercutaneously placed into the interspinous space and used to providedecompression of spinal stenosis by retaining the spinous process in thedistracted position. The implant also rigidly affixes the spinousprocesses of the vertebral bones on either side of the implantedinter-spinous space in order to retain and immobilize the vertebralbones relative to one another.

The device is preferably inserted from a first side of the interspinousspace. Rotatable members of the implant can be advanced across theinterspinous space from the first ipsilateral side to the secondcontralateral side, wherein the long axis of the deployable members canbe substantially parallel to the trajectory of device implantation. Alocking mechanism can be engaged in order to produce movement of therotatable members, wherein, in an embodiment, the rotatable members arerotated so that the long axis is substantially perpendicular to thetrajectory of device implantation. With further engagement of thelocking mechanism, the rotatable members can be translated towards thespinous process and towards an a second implant abutment surface that islocated on the side of the spinous processes that is opposite to that ofthe rotatable members.

As the locking mechanism is advanced further, the spinous processes areforcibly captured between the rotatable members and the second implantabutment surface. In a preferred embedment, the surfaces that abut thespinous process have spiked protrusions that penetrate the bony surfaceof the spinous processes and rigidly anchor into them. In a preferredembodiment, actuation of the locking mechanism produces rotation of therotatable arms, translation of the rotatable arms, the forcible captureof the spinous processes (with spike penetration of the bony surface ofthe spinous processes) between the rotatable members and second abutmentsurface, and locking the device in that configuration. The lockingmechanism is described as a single mechanism that produces theaforementioned functions, however, it is further contemplated that thelocking mechanism may consist of at least two mechanisms thatcollectively perform the aforementioned functions. The locking mechanismis preferably engaged and actuated through a deployment instrument thatis substantially positioned parallel to the trajectory of deviceimplantation. Further, the engagble segment of the locking mechanism ispreferably located on the ipsilateral side of the spinous processes atthe time of engagement by the deployment instrument (whereas therotatable members are located on the contralateral side of the spinousprocesses).

In an additional embodiment of implant use, the implant is advanced intothe posterior column (into the interspinous space) of a spinal segmentwhile another orthopedic implant is placed into the anterior column ofthe same spinal segment using a lateral approach to the anterior column.These operations are collectively known in the art as XLIF, DLiF and thelike. In this method both implants may be placed through a singlelateral skin incision or two immediately adjacent skin incisions toprovide a percutaneous or minimally invasive approach. Further, thismethod provides circumferential (i.e., anterior and posterior) expansionand decompression of the spinal so as to treat spinal stenosis thoughanterior and posterior decompression of the spinal canal.

In another embodiment of use, the device may be deployed through asingle incision that is posterior and lateral to the transverseprocesses of the spinal level to be implant. This surgical corridor andapproach is known to those of ordinary skill in the art as TLiF. Bonescrews can be advanced into the pedicle portion of bone on the side ofthe vertebrae that is ipsilateral to the incision. The screws arerigidly interconnected with a rod. The device disclosed herein is thenplaced through the same skin incision into the inter-spinous space.While contralateral pedicle screws may be also placed by the operatingsurgeon, the current inter-spinous device obviates the need forcontra-lateral screw placement.

In another device embodiment of the implant, the device rigidly affixesto the spinous process of one but not both adjacent vertebral bones inorder to attach the implant to just one vertebral bone. In a method ofuse of this device embodiment, the implant limits the extent ofvertebral extension but permits continued vertebral flexion. Comparablemethods of use to those already described are also contemplated.

Bone Fixation Device

FIG. 1 is a perspective view of an embodiment of a fixation device 105in an assembled and deployed state. FIG. 2 shows a perspective view ofthe device 105 in an exploded view. The fixation device 105 includes aplate member 120, rotation arm 180, and an advancing deployment member150, each of which will be described in more detail below. The fixationdevice 105 can also include a locking nut 210 and a screw 220 (shown inFIG. 2), which each play a role in translation, fixation and compressionof the device 105 into the deployed state. The device 105 can be used tointerconnect, fixate and compress the spinous process at one vertebrallevel with the spinous process of another adjacent vertebral level. Inuse, actuation of locking nut 210 produces rotation and translation ofrotation arms 180, thereby sandwiching and rigidly affixing the spinousprocess against plate member 120, as will be described in more detailbelow. The disclosed devices permit a surgeon to implant the device intothe posterior column of the spine from a lateral, or flank incision, aswill be discussed in more detail below.

As used herein, the anterior column generally designates a portion ofthe vertebral body and/or Functional Spinal Unit (FSU) that is situatedanterior to the posterior longitudinal ligament. Thus, its use in thisapplication encompasses both the anterior and middle column of Denis(see “The three column spine and its significance in the classificationof acute thoracolumbar spinal injuries.” Denis, F. Spine 1983November-December; 8(8):817-31, which is incorporated by reference inits entirety.) The illustrations and definitions of anatomicalstructures are known to those of ordinary skill in the art. They aredescribed in more detail in Atlas of Human Anatomy, by Frank Netter,third edition, Icon Learning Systems, Teterboro, N.J. The text is herebyincorporated by reference in its entirety. It should be appreciated thatthe directional language and terms regarding orientation such as upper,lower, upward, downward etc. are used throughout merely for convenienceof description and are not intended to be limiting.

FIGS. 3A-3C show diagrammatic representations of a spinal vertebral bone802 in multiple views. For clarity of illustration, the vertebral boneof FIGS. 3A-3C and those of other illustrations disclosed herein arerepresented schematically and it should be appreciated that actualvertebral bodies may include anatomical details that are not shown inthese figures. Further, it is understood that the vertebral bones at agiven level of the spinal column of a human or animal subject willcontain anatomical features that may not be present at other levels ofthe same spinal column. The illustrated vertebral bones are intended togenerically represent vertebral bones at any spinal level withoutlimitation. The disclosed devices and methods may be applied at anyapplicable spinal level.

Vertebral bone 802 contains an anteriorly-placed vertebral body 804, acentrally placed spinal canal 806 and posteriorly-placed lamina 808. Thepedicle segments 810 of vertebral bone 802 form the lateral aspect ofthe spinal canal 806 and connect the laminas 808 to the vertebral body804. The spinal canal 806 contains neural structures such as the spinalcord and/or nerves. A midline protrusion termed the spinous process SPextends posteriorly from the medial aspect of laminas 808. A protrusionextends laterally from each side of the posterior aspect of thevertebral bone 802 and is termed the transverse process TP. A righttransverse process RTP extends to the right and a left transverseprocess L TP extends to the left. A superior protrusion extendssuperiorly above the lamina 808 on each side of the vertebral midlineand is termed the superior articulating process SAP. An inferiorprotrusion extends inferiorly below the lamina 808 on each side of thevertebral midline and is termed the inferior articulating process IAP.Note that the posterior aspect of the pedicle 810 can be accessed at anindentation 811 in the vertebral bone 802 between the lateral aspect ofthe SAP and the medial aspect of the transverse process TP. In surgery,it can be common practice to anchor a bone fastener into the pedicleportion 810 of a vertebral bone 802 by inserting the fastener throughindentation 811 and into the underlying pedicle 810.

FIGS. 4A and 4B illustrate a FSU, which includes two adjacent vertebraeand the intervertebral disc between them. The intervertebral discresides between the inferior surface of the upper vertebral body and thesuperior surface of the lower vertebral body, although it is notspecifically shown in the figures. FIG. 4A shows the posterior surfaceof the adjacent vertebrae and the articulations between them. FIG. 4Bshows an oblique view. The FSU contains a three joint complex betweenthe two vertebral bones, with the intervertebral disc comprising theanterior joint. The posterior joints include a facet joint 814 on eachside of the midline, wherein the facet joint 814 contains thearticulation between the IAP of the superior vertebral bone and the SAPof the inferior bone.

The interspinous space is generally defined as the space immediatelybetween the spinous processes of a superior vertebral bone and thespinous process of an immediately adjacent inferior vertebral bone. Theinterspinous space is limited anteriorly by the spinal canal 806 andposteriorly by the posterior tip of the spinous processes. The rightlateral aspect of the interspinous space is limited by the right lateralside of the spinous processes whereas the left lateral aspect of theinterspinous space is limited by the left lateral side of the spinousprocesses. Note that the spinous processes of adjacent vertebral bonesmay be rotated in the axial plane relative to one another because ofbiological and/or individual variation (schematically shown in FIG. 4A).The interspinous space would continue to be defined as residing betweenthe spinous processes of the superior and inferior vertebral bones.

Now with respect to FIGS. 7A-7B, the plate member 120 of the fixationdevice 105 includes a generally flat, elongate platform having a first,bone-engaging surface 122 and an opposite, second surface 123. The firstsurface 122 of the plate member 120 can have one or more elements 126positioned on either side of a central protrusion 124. Elements 126 canbe sharpened such that they can penetrate, grip and can be driven intobone so as to anchor plate member 120 and compress the vertebral bone.The plate member 120 can have two elongate platform regions on eitherside of the central protrusion 124 or can have a single platform regionextending in a single direction (see FIGS. 31A-31 E). Also, the geometryof the elongate platform regions can vary (see also FIGS. 29A-29C).

The central protrusion 124 of the plate member 120 can include twoupward-extending elements 1240 on either side of a depression or notch1241. Full thickness holes 132 can be positioned on each side ofprotrusion 124 and can have a shape complementary to and adapted toaccept member 150 therethrough, as will be described in more detailbelow. A central opening 1242 can be positioned within notch 1241 andcan have a shape configured to accept screw 220. Unlike holes 132,central opening 1242 need not extend fully through plate member. Platemember 120 can have a coupling element 136 on the second surface 123opposite the central protrusion 124. The coupling element 136 caninclude a pair of opposing projections each of which can have a threadedouter surface 1360 and a notched inner surface 1364 (see FIG. 7B). Thecoupling element 136 can be used to couple the fixation device 105 to adeployment instrument for insertion and implantation, as will bedescribed in more detail below.

While plate 120 is shown having two rigid side arms with surfaces 122and spiked protrusions 126, it is contemplated that the arms canalternatively be made deployable—as shown for rotation members 180. Inthis embodiment, the device is positioned at the implantation site withthe long axis of the rotation arms of plate 120 positioned parallel tothe placement trajectory. The rotation arms are then rotated so that thelong axis of the rotation arms is positioned perpendicular to theplacement trajectory. In this way, plate 120 is made with deployablearms instead of the rigid arms.

FIGS. 8A-8S show perspective views of an advancing deployment member150. Member 150 is a generally cylindrical element having a central bore154 extending from a first region to a second region. The first regionof the member 150 through which central bore 154 extends has opposing,downward-extending elements 162. The second region of the member 150 hasopposing, upward-extending elements 160. The cross-section of theopposing, downward-extending elements 162 is complementary to holes 132in the plate member 120 such that the downward-extending elements 162can be drawn through the holes 132. The downward-extending elements 162are shown as being generally cylindrical on their outer surface althoughit should be appreciated that the geometry of these elements 162 (and assuch the geometry of the complementary holes 132 in the plate member120) can vary. The inner surface of elements 162 facing the central bore154 can have threads 156. Opposing elements 162 create a channel 165that intersects central bore 154. The channel 165 has an upper, expandedregion that forms a window 164 that is formed by upper surface 1644 andshoulders 1646.

Opposing, upward-extending elements 160 are shown as being partiallycylindrical on their outer surface although it should be appreciatedthat the geometry of these elements can vary. Upward-extending elements160 can have a generally flat geometry on their inner surface 163 facingthe bore 154. The elements 160 create a second channel 161 throughmember 150 that intersects the upper region of bore 154. Channel 161 hasa generally U-shaped geometry formed by inner surfaces 163 of opposingelements 160 and surface 158. The channel 161 in the upper region ofmember 150 is off-set by approximately 90 degrees from channel 165 andwindow 164. It should be appreciated that the angle of off-set can vary.Opposing, downward-extending elements 162 can be drawn through holes 132such that the elements 162 can interdigitate with the coupling element136 at the inferior surface of the plate member 120. The outer threadedsurface of the coupling element 136 is available for engagement by thedeployment instrument as will be described in more detail below. Theinner threads 156 of the elements 162 are also available for engagementby the locking nut 210, as will also be described below.

FIGS. 9A-98 show perspective views of a rotation arm 180. Although FIGS.9A-98 show a single rotation arm 180, it should be appreciated that thefixation device 105 can include two rotation arms 180 positioned inadjacent relationship to one another. It should also be appreciated thatthe paired rotation arms 180 can be coupled together to form anintegrated, articulating element or they can be separate components asshown in the figures. It should also be appreciated that the device caninclude a single rotation arm as will be described with respect to theembodiment of FIGS. 31A-31 E.

Rotation arms 180 have a generally flat, elongate extension region 185extending outward from a central, cylindrical hinge element 192. Theelongate extension region 185 of the rotation arms 180 are sized andconfigured to be contained within member 150 between opposing,upward-extending elements 160 inside bore 154. An end region 191 of eachhinge element 192 extends at least partially through a portion of window164. As such, the rotation arms 180 can translate upward and downwardthrough the bore and between upward-extending elements 160. This upwardand downward translation through the bore 154 is limited by the endregion 191 of each hinge element 192 extending through the window andabutting shoulder 1646 at a lower end of the window 164 and surfaces1644 at an upper end of the window 164.

Rotation arms 180 can have an upper surface 183 having an indentation186 positioned near the central hinge element 192. When the rotationarms 180 are positioned within the bore 154 of member 150, they areapproximately perpendicular to the plane of the plate member 120. Thehinge elements 192 are adjacent to one another and the end region 191 ofeach hinge element 192 extends at least partially through a portion ofwindow 164. The upper surface 183 of each rotation arm 180 is in contactwith one another or at least in close proximity to each other such thatthe indentations 186 on the upper surface 183 align with one anotherforming a pocket 187. The pocket 187 is configured to contain the headof screw 220 can reside (see for example FIG. 11A-11 8).

The rotation arms 180 are configured to rotate or articulate around theaxis of the hinge member 192 and relative to the plane of the platemember 120. Each extension region 185 can rotate away from one anotherand insert down through U-shaped channel 161 until the arms 180 approacha generally parallel position relative to the plate member 120. Like thebone-engaging surface of the plate member 120, rotation arms 180 canhave a bone-engaging surface 181 that can have one or more elements 182extending therefrom. Elements 182 can be somewhat sharpened such thatthey can penetrate the surface of the spinous processes, grip bone andaid in anchoring and compression of the arms 180 onto the vertebralbone.

Locking nut 219 is shown in FIGS. 10A-10C. Locking nut can have threads211 on an outer surface and an opening 213 available from an undersurface. In an embodiment, the opening 213 can be a hex head openingthat can be engaged with a driving tool having a hex shape. It should beappreciated that other configurations besides a hex shape are consideredherein. In the assembled state of fixation device 105, the nut 210 canthreadedly engage the inner threads 156 on opposing, downward-extendingelements 162 of member 150. Nut 210 can have a flattened upper surface212 configured to contact a portion of the plate member 120 positionedbetween holes 132 and below central protrusion 124. As the nut 210 isrotated it engages and draws downward the elements 162 of member 150.This threading action results in the elements 162 being drawn downwardthrough holes 132 and the upward translation of rotation arms 180through bore 154.

The fixation devices described herein can act to space apart the spinousprocesses and prevent their bottoming out against one another. Thefixation devices described herein also fixate the spinous processesrelative to one another by compressing them between the plate member andthe rotation arms. As will be described in more detail below, the samethreading rotation motions used to deploy the rotation arms is alsoemployed to urge the rotation arms and the plate member further togetherand compress the spinous processes therebetween.

The reversible transition of the assembled fixation device 105 from thefully withdrawn to the fully deployed state can be accomplished byrotation of threaded locking nut 210 and the consequent movement ofmember 150 relative to plate member 120. FIGS. 11A-11 B showcross-sectional views (see also FIG. 14A-14B for a side view) of theassembled fixation device 105 in the fully withdrawn state. Rotationarms 180 are largely contained within member 150 such that theextensions 185 extend into the upper region of member 150 betweenelements 160 and the hinge 192 is positioned within window 164. Screw220 extends through hole 1242 in central protrusion 124 such that theflanged region or the head of screw 220 is positioned within the pocket187. As described the pocket 187 is formed by the alignment of theindentations 186 on the upper surface of rotation arms 180 when in astate flush with one another. At least a portion of the end region 191of each side of hinge 192 extends through window 164. When the rotationarms 180 are in their downward-most fully withdrawn position, end region191 of the hinge element 192 abuts shoulders 1646 (see FIG. 14A). Aslocking nut 210 is rotated, downward-extending elements 162 of member150 are drawn through holes 132 of plate member 120. The hinge elements192 are translated upward through bore of member 150 until end region191 of the hinge elements 192 abuts surface 1644 (see FIG. 14B) as willbe described in more detail below.

FIGS. 12A-12B illustrate a cross-sectional view (see also FIGS. 15A-15Bfor a side view) of a partially deployed state of an assembled fixationdevice 105. Member 150 is shown having been drawn partially throughholes 132. Rotation arms 180 that had previously been in contact withshoulders 1646 are being translated upward through bore 154 and nowapproach upper surfaces 1644. As member 150 is drawn through holes 132in plate member 120, surfaces 1240 of protrusion 124 of plate 120 pressagainst surfaces 188 of rotation arms 180 and force the rotation arms180 upward through bore 154. Hinge element 192 can travel from shoulder1646 near a lower end of the window 164 toward the surface 1644 at theupper end of window 164. As the hinge element 192 approaches the upperend of window 164, the rotation arms 180 can begin to rotate around theaxis of hinge 192 such that arms 180 rotate away from one another (seeFIG. 15A). Once the hinge 192 of rotation arms 180 abuts the uppersurface 1644 of window 164 and no translation space remains, therotation arms 180 are urged to rotate around axis of hinge 192 andtravel down into U-shaped channel 161 (see FIG. 15B).

FIGS. 13A-13B show cross-sectional views (see also FIGS. 16A-16B for aside view) of a fixation device 105 in the deployed state. Rotation oflocking nut 210 has caused the rotation arms 180 to be forcibly rotatedtowards the parallel position with respect to the plane of the platemember 120. The upward-extending elements 1240 of protrusion 124 abutagainst corners 188 of each rotation arm 180. The rotation arms 180continue to rotate until they are in a substantially ninety degreeorientation relative to the plane of the plate member 120. Hingeelements 192 of rotation arms 180 at this point have fully migratedtowards and now abut the upper surfaces 1644.

Further rotation of locking nut 210 forces the downward translation ofthe bone-engaging surface 183 of rotation arms 180 towards bone-engagingsurface 122 of plate member 120 until the elements 126, 182 penetrateand compress the bone of the spinous processes therebetween. Note thatactuation of locking nut 210 produces rotation of rotation arms 180.After arms 180 have rotated into the desired relationship to platemember 120, further advancement of locking nut 210 produces advancementof the rotated arms 180 towards plate member 120 and the forcefulcapture of the spinous processes therebetween. In the currentembodiment, the rotated arms 180 then translate towards the plate member120 in order to rigidly affix the spinous process. However, it isunderstood that continued rotation of the rotation arms (or additionalcombination motion of rational and translational movement) could be usedto forcibly affix the spinous processes. FIGS. 16A-168 show anillustration of translational movement of the rotation arms 180 towardsplate 120 after rotation of the rotation arms.

The rotation arms 180 can be rotated and then translated towards platemember 120 so as rigidly capture the spinous processes using a singularmechanism. The rotation arms 180 and plate member 120 need not includeanother mechanism to forcibly compress the spinous processes. Further,no separate deployment instrument or clamp is required for the device torigidly capture the bone and lock the implant. In the preferredembedment of the current invention, a singular locking mechanismproduces rotation of the arms 180, compression of the spinous processesbetween arms 180 and plate 120, and retention of the plate in the lockedconfiguration after rigid fixation of the spinous processes.

While transition of the device from an open configuration (shown in FIG.14A, FIGS. 11A and 8) to a closed configuration (shown in FIG. 1, FIGS.13A and 8) has been described in detail, the device can reversiblytransition from the closed configuration to the open configuration byrotation of locking nut 210 in the opposite direction. With reverserotation of locking nut 210, surface 160 of member 150 moves away fromnut 210. With continued reverse rotation of nut 210, screw 220 iscaptured in pocket 187 of rotation arms 180. Further reverse rotation ofnut 210 produces forceful rotation back of rotation members 180 till theopen configuration of the device (FIG. 14A, FIGS. 11A and 8) is finallyachieved.

Deployment Instrument

The fixation device described herein can be implanted using a deploymentinstrument 605 that can be deployed percutaneously or usingminimally-invasive techniques (see FIG. 17A-17B). Deployment instrument605 includes an elongate shaft 610 and an actuation assembly 615extending through the elongate shaft 610. The elongate shaft 610 canhave a distal end with internal threads (not shown) configured toreversibly couple with outer threads 1360 of coupling elements 136 ofthe plate member 120. The deployment instrument 605 can be rigidlyattached to plate member 120 upon threading engagement between shaft 610and coupling elements 136 (see FIGS. 18A-18B).

The actuation assembly 615 can include an inner engagement member 6150having a central bore through which an inner driver 6160 extends. Bothinner engagement member 6150 and the inner driver 6160 are independentlytranslatable through the shaft 610 and with respect to each other. Innerengagement member 6150 has a distal portion 6154 having protrusions anda proximal handle portion 6155. The protrusions of the distal portion6154 can snugly fit within notched inner surface 1364 of couplingelement 136 of plate member 120. Handle portion 6155 can be externallyavailable outside the elongate shaft 610 and the patient such that itcan be used by the operator to translate and rotate the inner engagementmember 6150. Coupling between inner engagement member 6150 to platemember 120 couples them together and allows the operator to manipulatethe position of the fixation device 105, for example when fixationdevice 105 is positioned inside the patient. Inner driver 6160 has adistal driver portion 6164 and a proximal handle 6165. The distal driverportion 6164 can be a hex-driver configured to engage opening 213 of nut210. Rotation of inner driver 6160 produces rotation of locking nut 210to advance the locking nut 210 within the deployment member. Rotation ina first direction produces translation of the rotation arms 180 in afirst direction. Continued rotation of the locking nut 210 in the firstdirection places a compressive load onto the bony surfaces positionedbetween the rotation arm and the plate member. The compressive loadgenerated by rotation of the locking nut 210 is sufficient to urge thesharpened protrusions into the bony surfaces and immobilize the device105 relative to the spinous processes of the first and second vertebralbones. The compressive load on the bones is retained even afterdisengagement of the deployment instrument 605. Rotation of the lockingnut 210 in a second, opposite direction reverses the compressive loadand produces translation of the rotation arms 180 in the oppositedirection such that they rotate back into a position that isperpendicular to the plate member. Handle portion 6165 can be externallyavailable outside the elongate shaft 610 and the patient such that itcan be used by the operator to translate and rotate the inner driver6160.

Methods of Use

The implantation of the fixation devices will now be described. Asmentioned above, the devices perform a spacing function as well as thecompression and fixation of adjacent spinous processes such that thespinous process portions of the implanted vertebral bones are locked inposition relative to one another. These devices can be implanted using alateral approach and that same lateral approach can be used to deployand compress the spinous processes of vertebral bones being treated. Bypositioning the implant into the desired interspinous space and thenadvancing the locking nut 210, the rotation arms 180 can be urged torotate, translate and then forcibly capture and fixate the spinousprocesses that are adjacent to the implanted interspihous space betweenthe rotation arms 180 and plate 120.

It should be appreciated that the fixation devices described herein maybe used with any surgical approach to the posterior aspect of the spineand the disclosed fixation devices can be positioned in the spine usingany appropriate surgical method and/or surgical corridor. The fixationdevices described herein are particularly adapted to be placed through alateral surgical approach to the spine that starts with a surgicalincision in the posterior aspect of the patient's flank (i.e., sideaspect of the abdominal cavity). The fixation devices described hereinare also particularly adapted for use in stabilizing the posterioraspect of a spinal segment when a second orthopedic implant is implantedinto the disc space of that segment using a lateral, or flank, approachto the disc space. It must be noted that while the lateral approach isemployed in a preferred method of use, the implantation procedure of thedevice is not limited to a lateral approach to the interspinous space.

In an embodiment, the fixation devices are implanted into the lumbarspine using a flank incision and a lateral approach. In this method, thespinal level of desired device implantation can be localized under X-rayguidance. Referring back to FIG. 5, a skin incision can be placed in theflank at the approximate cephalad-caudal level of the implantation siteon the spine. FIG. 5 illustrates a cross sectional view of the torso atthe level of the lumbar spine. For clarity of illustration, the contentsare represented schematically and those skilled in the art willappreciate that an actual cross section of the human torso may includeanatomical details not shown in FIG. 5.

In preparation for percutaneous placement of the implant into a spinallevel, the patient can be, but is not necessarily, placed in a prone orlateral decubitus position. The level of the spine that is to beimplanted can be localized on X-ray in at least one plane. After thecustomary sterile preparation of the operative site, the surgeon canlocalize an incision point on the skin that is substantially directlylateral to the spinal segment that will be implanted. FIG. 6 shows aschematic representation of the posterior aspect of a patient 117. Theskin 118 overlying the back is shown. Lines Y show the lateral extent ofthe transverse processes of the spinal column. Assuming that the spinallevel to be accessed is at line Z, the surgeon can make an incision ator about circle X.

A lateral corridor “Y” (FIG. 5) can be made from the flank, through thepsoas muscle 116 and onto the lateral aspect of the disc space at thespinal level to be implanted. An implant can be placed through thecorridor Y and into disc space or onto the spine. The procedure is knownto those skilled in the art and known as the “XLIF” procedure (see“Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique foranterior lumbar interbody fusion.” By Ozgur, Aryan et al. in Spine J.2006 July-August; 6(4):435-43, which is hereby incorporated by referencein its entirety.)

A second lateral corridor “Z” (FIG. 5) can be made from the flank,through the posterior tissues lateral to the spine and onto the lateralaspect of the spinous processes and inter-spinous ligament of the levelto be implanted. While Corridor Y and Corridor Z are shown schematicallyas exiting the skin 118 of the flank at two different sites, bothcorridors can be made through a single, common skin incision on thepatient's flank. Once through the skin 118, the trajectory can be thenvaried so as to form an anatomically anterior Corridor Y and ananatomically posterior Corridor Z. The devices disclosed herein can beimplanted into the posterior aspect of a functional spinal unit using aCorridor Z and, at the same operation, an implant can be placed into oronto the anterior column (including disc space) of the same functionalspinal unit using a Corridor Y.

The method of device implantation is now illustrated. In an embodiment,a functional spinal unit FSU can be targeted for immobilization andfusion. FIG. 19A shows an illustrated spine with implant 305 positionedwithin the L4/L5 disc space. The level is the functional spinal unit FSUincluding the L4 and L5 vertebral bones and the intervening disc (notshown). An anterior implant 305 can be placed into the L4/L5 disc spaceas is known in the art. Implant 305 can be placed into the disc spaceusing a lateral procedure, such as, for example, XLIF, and a lateralsurgical corridor such as Corridor Y as described above with respect toFIGS. 5-6. A lateral corridor, such as Corridor Z, can be used toimplant fixation device 105. While the anterior implant 305 isillustrated as being implanted first, it is understood that either theanterior or posterior column implant may be positioned first. It shouldalso be understood that a different level of the spine can be targetedfor immobilization. For clarity of illustration, the vertebral bones ofthe illustrations presented herein are represented schematically andthose skilled in the art will appreciate that actual vertebral bodiesmay include anatomical details that are not shown in these figures. Itis also understood that the totality of the operation—from selection ofthe target spinal level to be decompressed, to insertion of the implantto the final placement of implant can be performed under X-ray guidance.Further, the operation can be performed using percutaneous orminimally-invasive surgical techniques with or without the aid ofelectrophysiological monitoring. The latter include techniques such aselectromyography (EMG) and are intended to alert the operating surgeonto the presence of nerves and other neural elements within the surgicalcorridor. EMG identification of nerves permits the surgeon to navigatethe surgical site with increased safety and to lessen the possibility ofnerve injury.

FIG. 198 shows a cylindrical tissue dilator 900 placed through a lateralcorridor, such as Corridor Z, to the spinous processes of L4 and L5 andthe inter-spinous space between them. FIGS. 20A-208 show the placementof a second tissue dilator 905 of greater diameter over the first tissuedilator 900. FIGS. 21A-21 8 show the placement of a third tissue dilator910 of still greater diameter over the second tissue dilator 905. FIGS.22A-228 illustrate the placement of a distraction device having tubularhalf-receptacles 915 of greater diameter than the third tissue dilator910. Half-receptacles 915 can be advanced to the L4/L5 inter-spinousspace by advancing them atop the third tissue dilator 910. Afterplacement of receptacles 915, the tissue dilators can be removed leavinga central channel 920 to the inter-spinous space (FIG. 228). Thedistraction device 925 can be used to distract each half receptacle 915,as shown in FIG. 23A. Note that the distraction device 925 illustratedis generic and that one of ordinary skill in art can provide otherdistraction devices or even sequential, tissue dilatation withprogressively larger tissue dilators that may produce the expandedtissue channel for device implantation. Further, each dilatation stepcan be checked by intra-operative X-rays at the time of each tissuedilator placement. EMG may be utilized to identify nerve elements andincrease procedure safety. FIG. 238 shows dilatation of the spacebetween the spinous processes (inter-spinous space) and the perforationof the ligament contained therein.

FIG. 24A-24B show the deployment instrument 605 coupled at a distal endto a fixation device 105 in the fully withdrawn state. The deploymentinstrument 605 and the threadedly attached fixation device 105 are thenguided to the interspinous space and the distal end of the fixationdevice 105 is advanced through the space until at least the channel 161of member 150 is posterior to the midline of the spinous process. Byrotating inner driver 6160, locking nut 210 is rotated and threadedlyadvanced so that device 105 is transitioned from fully withdrawn (open)state to the fully deployed (closed) state, as previously described.FIG. 25A illustrates the fully deployed fixation device 105 prior toremoval of the deployment instrument 605 and receptacles 915.

FIG. 25B and FIGS. 26A-26B show the implanted device 105 with thedeployment instrument 605 and receptacles 915 removed. Elements 182 ofrotation arms 180 and elements 126 of plate member 120 forciblypenetrate the bone surface and capture each of the L4 and L5 spinousprocesses. The spinous processes are rigidly immobilized relative to oneanother by the implanted device 105. As previously mentioned, actuationand advancement of locking nut 210 produces rotation of the rotationarms 180, translation of the rotation arms 180 and the forcible captureof the spinous processes adjacent to the implanted inter-spinous space.In addition, the advanced locking nut 210 serves as a locking mechanismthat retains the implant in the deployed configuration. Continuedadvancement of the locking nut 210 produces advancement of the rotationarms 180 towards the plate member 120 and a placement of compressiveloads onto the bony surfaces that they abut and engage. The compressiveload is sufficient to immobilize the device relative to the bonysurfaces. The sharpened protrusions on the rotation arms 180 and theplate member 120 are forcibly advanced such that they penetrate the bonysurfaces. All of these features can be produced though the disclosedmechanism by the singular advancement of a singular locking nut 210.

In the implanted configuration, surface 162 is positioned in theinter-spinous space and abuts the inferior aspect of the superiorspinous process and the superior aspect of the inferior spinous process.Surface 162 resists vertebral extension by limiting the extent to whichthe spinous processes can travel towards one another. Vertebral flexionis also prevented since the captured spinous processes cannot move awayfrom one another. That is, the implant device 105 immobilizes theadjacent spinous processes.

Bone graft material can be employed in the posterior column tosupplement the fixation and bone graft material of the anterior columnthat is provided by the implant 305. FIG. 27 A shows bone graft material405 (which may include an allograft bone that is machined into theillustrated shapes) having a “T” or “H” shape, but it should beappreciated that other geometries are considered herein. Alternatively,an implant having a hollow central cavity can be used, such as a spaceror a fusion cage (see U.S. Pat. No. 6,375,681, which is herebyincorporated by reference in its entirety) that can be filled with bonegraft material. In use, the posterior aspect of the L4 lamina and theposterior aspect of the L5 lamina, as well as the L4 and L5 spinousprocesses can be denuded of muscle and other soft tissues and the outerbony surface can be de-corticated in preparation for acceptance of abone graft material. Bone graft material 405 (or a fusion cage) is thenplaced in apposition with the posterior aspect of the lamina and aspectof the spinous process that is ipsilateral to the side of deviceinsertion. FIG. 27B illustrates use of the graft material 405 positionedanterior to fixation device 105. Note that the bone graft materialextends from the lamina and or spinous process of L4 to the laminaand/or spinous process of L5, wherein the bone graft material is adaptedto form a fusion mass between the posterior bony elements of L4 and theposterior bony elements of L5.

Another method of device implantation is shown in FIGS. 27C and 270,which show a schematic illustration of the approximate location ofincision site “M” and soft tissue corridor “N”, which extends fromincision “M” to the underlying interspinous space. In this methodembodiment, an anterior column implant is placed using any known methodfor implant placement. These known methods include XUF (using corridor“0”), AUF, AXUF, GUF, or the like. The tissue corridor is not shown foreach of these known procedures. In this method, corridor “N” is apostero-lateral approach to the inter-spinous space instead of thedirectly lateral approach (for example, corridor “Z”) of FIG. 5.Otherwise, the method of device implantation is as already disclosedabove and illustrated in FIGS. 19A through 27.

Another method is shown in FIG. 28A. In this embodiment, a portion ofthe facet joint is removed and a bone fusion implant is placed into theanterior column through the cavity created by the facet resection. Thisoperation is known to those of ordinary skill in the art as aTrans-foraminal Lumbar Interbody Fusion (TLIF). A bone screw 1545 can beplaced into the pedicle portion of bone at each of the upper (L4 level)and lower (L5 level) vertebral bones. A rod 1560 can be used to rigidlyinterconnect the screws 1545. The screws/rod can be placed on one sideof the vertebral midline and a fixation device 105 as described abovecan be used to supplement the uni-lateral screw/rod fixation. In apreferred method of use, the implant 105 is implanted placed though thesame (single) skin incision used to implant the screws 1545 andinter-connecting rod 1560. FIGS. 288 and 28C show a schematicillustration of the approximate location of incision site “X” and softtissue corridor “K”, which extends from incision “X” to the underlyingbone. In a first preferred embodiment, all implants are placedipsilateral to the skin incision “X”, wherein an implant 1546 ispositioned into the disc space of the anterior column, two screws 1545and an interconnecting rod 1560, as well as inter-spinous implant 105are collectively delivered though corridor “K”. There is no separateskin incision that is placed on the contralateral side of the spinousprocesses and no bone screws or other orthopedic implants are placed onthe contralateral side of the spinous process through a separatecontralateral skin incision.

In a second embodiment of device use, the method illustrated in FIG. 28Ais used. However, a separate skin incision is made on the contralateralside of the spinous processes and bone screws or other orthopedicimplants are placed on the contralateral side of the spinous processthrough a separate contralateral skin incision.

OTHER EMBODIMENTS

As described above, the fixation devices described herein as well as thecomponents of the devices can vary in their geometry and configuration.For example, device 505 as shown in FIGS. 29A-29C can include rotationarms 580 and a plate member 520 having a “Z” configuration. In thisembodiment, the rotation arms, advancing deployment member, locking nutand retention screw (similar to screw 220 of device 105) aresubstantially equivalent to the comparable components of device 105.Plate 520 differs from plate 120 in that the former has the “Z”configuration illustrated in FIGS. 29A-29C. Further, advancingdeployment member is positioned in a rotated orientation relative toplate 520 so that the rotation arms 580, when rotationally deployed, canrest opposite each of the spike-bearing portions of plate 520 as shownin FIGS. 29A-C.

Device 505 permits the implantation of adjacent levels withoutinterference from neighboring devices. FIGS. 30A-30C illustrate animplanted device 505 at each of two adjacent functional spinal units.The two implants 505 immobilize three adjacent vertebral bones. While ananterior column implant is not shown, it understood that the presentinvention contemplates placement of device 505 in conjunction withanterior column implants.

FIGS. 31A-31 E show another embodiment of a fixation device 705. In thisembodiment, the plate member 720 includes a single bone-engaging surface722 extending laterally to only one side of the central protrusion 724.Similarly, the device 705 has a single rotation arm 780 that translatesthrough the member 750 as the screw 710 is rotated and draws elements762 down through holes 732. As best shown in FIGS. 318-31 E, as the nut710 threads with elements 762 and draws them down through holes 732, thecentral protrusion 724 having screw 721 inserted therethrough acts tourge the rotation arm 780 upwards through the bore of member 750. Hingeelement 792 of rotation arm 780 abuts surface 744 of window 764.Rotation arm 780 begins to rotate around the axis of hinge element 792from a perpendicular position relative to the plate member 720 until thebone-engaging surfaces 783, 722 of the rotation arm 780 and the platemember 720, respectively, are parallel to one another (see FIG. 31D).The nut 710 can be further rotated and the elements 762 drawn furtherthrough holes 732 such that bone-engaging surfaces 783, 722 of therotation arm 780 and the plate member 720 are urged further translatedtowards one another until the bone of the spinous process engagedtherebetween is compressed and penetrated by elements 726 and 782 (seeFIG. 31 E).

The embodiment of the FIGS. 31A-31 E is shown implanted onto aschematically represented spine in FIGS. 32A and 32B. In the presentembodiment, member 762 is positioned in the inter-spinous space with theouter surface abutting the inferior aspect of the superior spinousprocess and the superior aspect of the inferior spinous process. Device705 functions to limit vertebral extension and the extent to which thespinous processes can move towards one another at the implanted level.However, the implanted device 705 does not limit vertebral flexion orthe extent of which the spinous processes may move away from oneanother. Unlike device 105 which is used to immobilize and fusevertebral bone, device 705 is preferably used to maintain the relativemovement between the vertebral bones but limit the extent of vertebralextension alone.

The disclosed devices or any of their components can be made of anybiologically adaptable or compatible materials. Materials consideredacceptable for biological implantation are well known and include, butare not limited to, stainless steel, titanium, tantalum, combinationmetallic alloys, various plastics (such as PEEK and the like), resins,ceramics, biologically absorbable materials and the like. Any componentsmay be also coated/made with osteo-conductive (such as deminerized bonematrix, hydroxyapatite, and the like) and/or osteo-inductive (such asTransforming Growth Factor “TGF-B,” Platelet-Derived Growth Factor“PDGF,” Bone-Morphogenic Protein “BMP,” and the like) bio-activematerials that promote bone formation. Further, any surface may be madewith a porous ingrowth surface (such as titanium wire mesh,plasma-sprayed titanium, tantalum, porous CoCr, and the like), providedwith a bioactive coating, made using tantalum, and/or helical rosettecarbon nanotubes (or other carbon nanotube-based coating) in order topromote bone in-growth or establish a mineralized connection between thebone and the implant, and reduce the likelihood of implant loosening.Lastly, the system or any of its components can also be entirely orpartially made of a shape memory material or other deformable material.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of what is claimed or of what maybe claimed, but rather as descriptions of features specific toparticular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Only a few examples and implementations are disclosed.Variations, modifications and enhancements to the described examples andimplementations and other implementations may be made based on what isdisclosed.

What is claimed is:
 1. A method for stabilizing a spinal segmentcomprising a superior vertebral bone, an immediately adjacent inferiorvertebral bone and an intervening intervertebral disc space, said methodcomprising: identifying said spinal segment using an imaging modality;creating a first corridor configured to extend through a psoas muscleand onto a lateral side surface of said intervertebral disc space;advancing a first implant at least partially into said intervertebraldisc space using said first corridor; advancing a second implant througha second corridor configured to extend onto a lateral aspect of aninterspinous space positioned between a spinous process of said superiorvertebral bone and a spinous process of said inferior vertebral bone,said second corridor being ipsilateral to said first corridor, and saidsecond implant comprising: an elongated body configured to extend alonga longitudinal axis from a proximal segment to a distal segment; a firstbone abutment member configured to extend along a longitudinal axis froma proximal to a distal end and movably coupled to said distal segment ofsaid elongated body; and a second bone abutment member configured toextend along a longitudinal axis from a proximal to a distal end andcoupled to said proximal segment of said elongated body; advancing saidsecond implant at least partially into said interspinous space, saidfirst and said second bone abutment members of said second implant beingpositioned on opposing sides of at least one of said spinous process ofsaid superior vertebral bone and/or said spinous process of saidinferior vertebral bone; performing a first actuation of a lockingmechanism of said second implant, said first actuation thereof causingrotation of said longitudinal axis of said first bone abutment member toa greater angle with respect to said longitudinal axis of said elongatedbody; performing a second actuation of said locking mechanism of saidsecond implant, said second actuation thereof causing translation ofsaid bone abutment members toward one another without further rotationof said first bone abutment member relative to said elongated body; andimmobilizing said spinous process of said superior vertebral bonerelative to said spinous process of said inferior vertebral bone.
 2. Themethod of claim 1, wherein said act of advancing said first implant intosaid intervertebral disc space is performed through a first skinincision and said act of advancing said second implant onto saidinterspinous space is performed through a second skin incision.
 3. Themethod of claim 2, wherein said first and said second skin incisionscomprise separate but adjacent incisions.
 4. The method of claim 1,wherein said second corridor is produced via placement of a surgicalretractor assembly.
 5. The method of claim 4, wherein said secondcorridor is produced via sequential addition of retractors ofprogressively greater diameter.
 6. The method of claim 1, furthercomprising positioning bone forming material at least partially withinsaid interspinous space.
 7. The method of claim 1, wherein said firstand said second corridors are accessed through said same skin incision.8. The method of claim 1, wherein said first and said second corridorsare substantially parallel.
 9. The method of claim 1, wherein said actof advancing said first bone abutment member onto said first lateralside aspect of said spinous process is produced via actuation of amechanism at least partially situated within said second implant. 10.The method of claim 1, wherein said first implant and/or said secondimplant is at least partially manufactured from a metallic alloy.
 11. Amethod for fusion of a spinal segment comprising a superior vertebralbone, an immediately adjacent inferior vertebral bone and an interveningintervertebral disc space of a subject, said method comprising:identifying said spinal segment on an imaging modality; advancing afirst implant into said intervertebral disc space using a first corridorwithin said subject that extends from a first lateral skin incision andonto a lateral side surface of said intervertebral disc space;positioning said first implant within said intervertebral disc spacethrough said first corridor; advancing a second implant through a secondcorridor and onto a lateral aspect of an interspinous space, saidinterspinous space being positioned between a spinous process of saidsuperior vertebral bone and a spinous process of said inferior vertebralbone, said second implant comprising: an elongated body configured toextend along a longitudinal axis from a proximal segment to a distalsegment; a first bone abutment member configured to extend along alongitudinal axis from a proximal to a distal end and movably coupled tosaid distal segment of said elongated body; and a second bone abutmentmember configured to extend along a longitudinal axis from a proximal toa distal end and coupled to said proximal segment of said elongatedbody; positioning said elongated body of said second implant at leastpartially within said interspinous space, said first bone abutmentmember being positioned on a side of said interspinous spacecontralateral to said first lateral skin incision, and said second boneabutment member being positioned on a side of said interspinous spaceipsilateral to said first lateral skin incision; actuating a mechanismof said second implant, said act of actuating advancing said first andsaid second bone abutment members towards one another; and immobilizingsaid spinous process of said superior vertebral bone relative to saidspinous process of said inferior vertebral bone, wherein said lockingmechanism of said second implant is further configured to: (i) upon afirst actuation thereof, cause rotation of said longitudinal axis ofsaid first bone abutment member away from a parallel position relativeto said longitudinal axis of said elongated body; and (ii) upon asubsequent actuation thereof, cause translation of said bone abutmentmembers toward one another without causing a further rotation of saidfirst bone abutment member relative to said elongated body.
 12. Themethod of claim 11, wherein: said act of advancing said first implantinto said intervertebral disc space is performed through said firstlateral skin incision; and said act of advancing said second implantonto said interspinous space is performed through a second skinincision.
 13. The method of claim 12, wherein said first and said secondskin incisions comprise separate incisions.
 14. The method of claim 12,wherein said first and said second corridors are accessed through a sameone of said first and second skin incisions.
 15. The method of claim 11,wherein said second corridor is produced via placement of a surgicalretractor assembly.
 16. The method of claim 15, wherein said secondcorridor is produced via sequential addition of retractors ofprogressively greater diameter.
 17. The method of claim 11, furthercomprising positioning bone forming material at least partially withinsaid interspinous space and adjacent to said second implant.
 18. Themethod of claim 11, wherein said act of advancing said first and saidsecond bone abutment members towards one another further comprisescausing a spinous process of said superior or inferior vertebral bone tobe compressed therebetween.
 19. The method of claim 11, wherein at leastone of said first and second bone abutment members further comprises oneor more features configured to potentiate implant anchor onto bone. 20.The method of claim 11, wherein at least said first actuation of saidmechanism is further configured to be reversible.
 21. The method ofclaim 11, wherein a locking instrument is used to actuate saidmechanism.
 22. The method of claim 11, wherein at least one of saidfirst implant or said second implant is at least partially manufacturedfrom a metallic alloy.
 23. The method of claim 11, wherein at least oneof said first implant or said second implant is at least partiallymanufactured from a plastic material.
 24. A method for anterior andposterior decompression of a target spinal canal segment that ispositioned between a superior vertebral bone and an inferior vertebralbone, said method comprising: identifying said target segment; placing afirst implant within a disc space that is positioned between saidsuperior vertebral bone and said inferior vertebral using a firstcorridor configured to extend from a posterior skin incision and throughat least a portion of a facet joint that forms an articulation betweensaid superior and inferior vertebral bones; advancing a second implantinto an interspinous space between a spinous process of each of saidsuperior and inferior vertebral bones, said second implant comprising:an elongated body configured to extend along a longitudinal axis from aproximal segment to a distal segment; a first bone abutment memberconfigured to extend along a longitudinal axis from a proximal to adistal end and movably coupled to said distal segment of said elongatedbody; and a second bone abutment member configured to extend along alongitudinal axis from a proximal to a distal end and coupled to saidproximal segment of said elongated body; positioning said first andsecond bone abutment members of said second implant on opposing sides ofat least one of said spinous processes of said superior and inferiorvertebral bones; performing a first actuation of a locking mechanism ofsaid second implant, said first actuation thereof causing rotation ofsaid longitudinal axis of said first bone abutment member to a greaterangle with respect to said longitudinal axis of said elongated body;performing a subsequent actuation of said locking mechanism of saidsecond implant, said subsequent actuation thereof causing translation ofsaid bone abutment members toward one another without further rotationof said first bone abutment member relative to said elongated body; andimmobilizing said spinous process of said superior vertebral bonerelative to said spinous process of said inferior vertebral bone. 25.The method of claim 24, wherein a locking instrument is used to actuatesaid locking mechanism and produce said first and second actuations. 26.The method of claim 25, wherein said locking mechanism is adapted toretain a compressive load placed onto at least one of said spinousprocesses of said superior and inferior vertebral bones afterdisengagement of said locking instrument from said locking mechanism.27. The method of claim 24, further comprising anchoring a first bonescrew into a pedicle of said superior vertebral bone, anchoring a secondbone screw into pedicle of said inferior vertebral bone and connectingsaid first and second bone screws with a rod.
 28. The method of claim24, further comprising positioning bone fusion material at leastpartially within said interspinous space.
 29. The method of claim 24,wherein said act of advancing said first implant into saidintervertebral disc space and said act of advancing said second implantonto said interspinous space are performed through said posterior skinincision.
 30. The method of claim 24, wherein said translation of saidfirst and second bone abutment members towards one another causes atleast one spinous process of said superior and inferior vertebral bonesto be compressed therebetween.
 31. The method of claim 24, wherein atleast one of said first and second bone abutment members comprises oneor more of features configured to potentiate implant anchor onto bone.32. The method of claim 24, wherein a fourth bone abutment member iscoupled to said distal segment of said elongated body, said firstactuation of said locking mechanism concurrently rotating each of saidfirst and fourth bone abutment members relative to said elongated body.33. The method of claim 24, wherein at least said first actuation ofsaid locking mechanism is further configured to be reversible.
 34. Themethod of claim 24, wherein said first implant and/or said secondimplant is at least partially manufactured from a metallic alloy. 35.The method of claim 24, wherein said first implant and/or said secondimplant is at least partially manufactured from a plastic material. 36.A method for bony fusion of a first vertebral bone, an immediatelyadjacent second vertebral bone, and an intervening intervertebral discspace, said method comprising: identifying said first and secondvertebral bones on an imaging modality; placing a skin incisionposterior to a posterior aspect of a pedicle of an inferior one of saidfirst and second vertebral bones; developing a first corridor to anipsilateral facet joint from said incision, said facet joint comprisingan articulation between said first and second vertebral bones; removingat least a portion of said facet joint; advancing at least a segment ofa first implant into said intervertebral disc space through atrans-foraminal corridor; developing a second corridor to said lateralaspect of an inter-spinous space, said inter-spinous space beingpositioned between a spinous process of said first vertebral bone and aspinous process of said second vertebral bone; positioning a secondimplant within said interspinous space, said second implant comprising:an elongated body configured to extend along a longitudinal axis from aproximal segment to a distal segment; a first bone abutment memberconfigured to extend along a longitudinal axis from a proximal to adistal end and movably coupled to said distal segment of said elongatedbody; and a second bone abutment member configured to extend along alongitudinal axis from a proximal to a distal end and coupled to saidproximal segment of said elongated body; positioning said elongated bodyof said second implant at least partially within said interspinousspace, said first bone abutment member being positioned on a side ofsaid interspinous space contralateral to said skin incision, and saidsecond bone abutment member being positioned on a side of saidinterspinous space ipsilateral to said skin incision; actuating anadvancement mechanism of said second implant to advance said first andsaid second bone abutment members towards one another; and immobilizingsaid spinous process of said first vertebral bone relative to saidspinous process of said second vertebral bone, wherein said advancementmechanism of said second implant is further configured to: (i) upon afirst actuation thereof, cause rotation of said longitudinal axis ofsaid first bone abutment member away from a parallel position relativeto said longitudinal axis of said elongated body; and (ii) upon asubsequent actuation thereof, cause translation of said bone abutmentmembers toward one another without causing a further rotation of saidfirst bone abutment member relative to said elongated body.
 37. Themethod of claim 36, further comprising: anchoring a first bone screwinto a pedicle of said first vertebral bone; anchoring a second bonescrew into a pedicle of said second vertebral bone; and connecting saidfirst and second bone screws via a rod.
 38. The method of claim 36,further comprising positioning bone fusion material at least partiallywithin said interspinous space.
 39. The method of claim 36, wherein saidact of advancing said first implant into said intervertebral disc spaceand said act of advancing said second implant onto said interspinousspace are performed through said skin incision.
 40. The method of claim36, wherein said translation of said first and second bone abutmentmembers towards one another causes at least one spinous process of saidfirst and second vertebral bones to be compressed therebetween.
 41. Themethod of claim 36, wherein at least one of said first and second boneabutment members comprises one or more of features configured topotentiate implant anchor onto bone.
 42. The method of claim 36, whereinat least said first actuation of said advancement mechanism is furtherconfigured to be reversible.
 43. The method of claim 36, wherein alocking instrument is used to actuate said advancement mechanism andproduce said first and second actuations.
 44. The method of claim 36,wherein at least one of said first implant or said second implant is atleast partially manufactured from a metallic alloy.
 45. The method ofclaim 36, wherein at least one of said first implant or said secondimplant is at least partially manufactured from a plastic material. 46.A method for bony fusion of a first vertebral bone, an immediatelyadjacent second vertebral bone, and an intervening intervertebral discspace, said method comprising: identifying said first and secondvertebral bones on an imaging modality; placing a skin incisionposterior to a posterior aspect of a pedicle of an inferior one of saidfirst and second vertebral bones; developing a first corridor to anipsilateral facet joint from said incision, said facet joint comprisingan articulation between said first and second vertebral bones; removingat least a portion of said facet joint; advancing at least a segment ofa first implant into said intervertebral disc space through atrans-foraminal corridor; developing a second corridor to said lateralaspect of an inter-spinous space, said inter-spinous space beingpositioned between a spinous process of said first vertebral bone and aspinous process of said second vertebral bone; positioning a secondimplant within said interspinous space, said second implant comprising:an elongated body configured to extend along a longitudinal axis from aproximal segment to a distal segment; a first bone abutment memberconfigured to extend along a longitudinal axis from a proximal to adistal end and movably coupled to said distal segment of said elongatedbody; and a second bone abutment member configured to extend along alongitudinal axis from a proximal to a distal end and coupled to saidproximal segment of said elongated body; positioning said elongated bodyof said second implant at least partially within said interspinousspace, said first bone abutment member being positioned on a side ofsaid interspinous space contralateral to said skin incision, and saidsecond bone abutment member being positioned on a side of saidinterspinous space ipsilateral to said skin incision; actuating alocking mechanism of said second orthopedic implant to advance saidfirst and said second bone abutment members towards one another; andimmobilizing said spinous process of said first vertebral bone relativeto said spinous process of said second vertebral bone.
 47. The method ofclaim 46, further comprising anchoring a first bone screw into a pedicleof said first vertebral bone, anchoring a second bone screw into apedicle of said second vertebral bone and connecting said first andsecond bone screws via a rod.
 48. The method of claim 46, furthercomprising positioning bone fusion material at least partially withinsaid interspinous space.
 49. The method of claim 46, wherein said act ofadvancing said first implant into said intervertebral disc and said actof advancing said second implant onto said interspinous space areperformed through said skin incision.
 50. The method of claim 46,wherein said translation of said first and second bone abutment memberstowards one another causes at least one spinous process of said firstand second vertebral bones to be compressed therebetween.
 51. The methodof claim 46, wherein at least one of said first and second bone abutmentmembers comprises one or more of features configured to potentiateimplant anchor onto bone.